gudid
Primary ID: 1
AMSure Add-A-Foley Tray (UDI 1)
Manufactured by AMSINO INTERNATIONAL, INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for AMSure Add-A-Foley Tray - Primary ID 1
Device Regulatory Overview
The AMSure Add-A-Foley Tray (Model/Catalog Number: 1) is a medical device manufactured by AMSINO INTERNATIONAL, INC.. This product is indexed under FDA Product Code / Category Classification FCM within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 1
- Product Code / EMDN
- FCM
- Device Name
- 400mL Urine Meter attached to 2600mL Drainage Bag (China) with: Universal hook hangerBed sheet clampT-valve drainage outletAir ventAMSafe needleless sampling port30 mL Pre-Filled Syringe with Sterile Water (China)
- Database Sync Date
- 2026-08-09 10:01:11
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of AMSure Add-A-Foley Tray?
The registered manufacturer of record for AMSure Add-A-Foley Tray is AMSINO INTERNATIONAL, INC..
What is the Primary UDI-DI identifier for AMSure Add-A-Foley Tray?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 1.
What classification code is assigned to this device?
This device is registered under product classification code FCM.
Similar Classification Devices (FCM)
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